Reported Jun 8, 2022 · Ongoing
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.
- Lot codes and dates
- Model NumberC304-HIS
- GTIN00763000147013
- Lot Numbers
00109488640010953298001095815000109612220010971148001101753900110202630011022874001102520200110285740011031177
- Amount recalled
- 1385 devices
Where it was sold
Why it was recalled
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
This product could cause temporary or reversible health problems — stop using it.
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